Wire electrode devices for tonsillectomy and adenoidectomy

ABSTRACT

Monopolar electrosurgery devices adapted for resecting tonsil and adenoid tissue. The devices minimize thermal injury by employing a plasma generated by pulsed electrical signals to precisely and effectively cut or coagulate the tissues. Suction may also be applied to the tissues to enhance the cutting, coagulation, and tissue manipulation functions. The devices include an interchangeable tip that may be switched for another tip, depending on which tip may be more suitable for tonsillectomy or adenoidectomy.

CROSS-REFERENCE TO RELATED APPLICATION

This claims the benefit under 35 U.S.C. §119(e) of U.S. ProvisionalApplication No. 61/495,853, filed Jun. 10, 2011, the contents of whichis incorporated herein by reference in its entirety.

FIELD

The field is electrosurgery, and in particular, tonsillectomy andadenoidectomy.

BACKGROUND

The tonsils and adenoids are generally located in the back of the human(mammalian) nose and throat, and are part of the lymphatic system thatsamples bacteria and viruses entering the body. Once sampled, the immunesystem is activated to produce antibodies that fight infection. Whenbacteria and viruses become trapped in the tonsils and adenoids, thesetissues are able to break down their cell wall and deliver the fragmentsto areas of the body that produce antibodies modeled against thefragments. However, repeated inflammation of the tonsils and adenoidsimpedes their ability to destroy the bacteria that become entrappedtherein, resulting in bacterial colonization of these tissues. Thecolonies of bacteria can then serve as a reservoir for repeatedinfections (e.g., tonsillitis or ear infections). Tonsillectomy and/oradenoidectomy may be indicated when antibiotic treatment fails to removethe bacterial reservoir. Tonsil tissue may also need to be removed if itenlarges to the point of causing airway obstruction, which may manifestas snoring or sleep apnea. Some individuals are also born with largertonsils that are more prone to cause obstruction. Adenoidectomy may alsobe required to remove adenoid tissue when ear pain persists, or whennose breathing or function of the Eustachian tubes is impaired.

The devices and techniques used for tonsillectomy and adenoidectomy willusually depend on such factors as the type and amount of tissue to beremoved and surgeon preference. The two procedures are routinelyperformed together. A common method for tonsillectomy and adenoidectomyemploys cold surgical dissection. Here tissue is removed using a scalpelor other sharp instrument such as a curette or punch device. Sharpdissection oftentimes results in heavy bleeding, which can be stemmedwith electrocautery.

In addition to coagulation, electrosurgery devices (e.g.,suction-tipped, blade, or needle tip Bovies) may also be employed toresect tonsil or adenoid tissue. The suction tipped Bovie typically hasa hollow center to suction blood, secretions, and smoke from thesurgical field, and a rim of metal for cutting and coagulation. Aseparate aspirator is used when blade and needle tip Bovies are used.Although the use of Bovies reduces blood loss intraoperatively incomparison to cold techniques, it is associated with increasedpostoperative pain due to spread of the thermal injury from the heat ofelectrosurgery (average temperatures are above 300° C.). Despite theirincreased thermal injury profile, use of the Bovie remains the mostpopular method of tonsil removal in the U.S. due to its speed,convenience, universal availability, and surgeon familiarity with thedevice.

Other energy-type devices have been commercialized that attempt tominimize thermal injury. These include the Harmonic Scalpel® system(Ethicon Endo-Surgery, Cincinnati, Ohio) (ultrasonic energy), lasers(e.g., KTP, Nd:YAG, or CO₂ lasers), and Coblation® devices (Arthrocare,Austin, Tex.) (bipolar radiofrequency ablation). However, the decreasein thermal injury provided by these devices is questionable. Even ifthey do result in less thermal injury, it is offset by reduced controlof bleeding and surrounding tissue trauma, longer operative times, orless precise cutting. Some of the instruments also obscure the surgicalfield and are difficult to maneuver due to their large size.

When Coblation® devices are employed, the procedure requires salinedelivery in order to establish an electrosurgical effect. Pre-operativetime is prolonged due to the inclusion of the saline delivery set-up.Coblation® device aspiration lumens also periodically clog during theprocedure, which causes saline to pool in the patient's throat. Thepooled saline must then be suctioned using a separate aspirator.Additionally, the Coblation® device lumen typically has to be manuallycleared in order to finish the surgery.

Accordingly, new devices for resecting tonsil and adenoid tissue wouldbe useful. In particular, devices that precisely cut tonsil and adenoidtissue while effectively controlling bleeding and surrounding tissuetrauma would be desirable. Devices that provide easier access to thetonsils and adenoids and manipulation of those tissues would also bedesirable.

SUMMARY

Described here (but not limiting) are electrically “monopolar”electrosurgical devices that optimize many functions required inperforming tonsillectomy or adenoidectomy while minimizing side-effects(the return electrode is applied to the patient remote from the activeelectrode). For example, the precise cutting of tissue is provided by athin layer of plasma that surrounds the electrode edge. In someinstances the plasma is formed with pulsed radiofrequency (RF)energizing waveforms having a lower range of duty cycles so that tissuehas time to cool between pulses. This coupled with the mostly insulatedtips helps to reduce thermal damage by limiting the extent of thermaldiffusion from the electrode into surrounding tissue. Continuous or 100%duty cycle energizing waveforms may also be employed when faster cuttingis desired. When hemostasis is needed, suction and plasma may bedirectly applied to the target area to mechanically and electricallystop the bleeding. Tension of the electrode surface(s) against thetissue is generally optimized with a configuration where suction isapplied through the electrode or in very close proximity thereto. Theaspiration port being closely associated with the blade allows a “dryfield” surgical technique. This is advantageous here because it allows aconcave blade to function well unlike the case with a wet field. This isbecause current flows from the blade to the tissue only via the part ofthe blade in actual tissue contact with the dry field. Further, thesuction decreases the width of the tissue in contact with the blade,further reducing the contact area and also further drying the tissue.Given that it may be difficult to access the portions of the oropharynxand nasopharynx where the tonsils and adenoids are located, the devicesdescribed herein may be designed with one or more malleable portions sothat they can be shaped to improve access to these regions and/oraccommodate variations in patient anatomy.

It has been found that for ENT (ear-nose-throat) surgery as describedhere, a monopolar approach is advantageous because the remote returnelectrode guarantees good electrical contact. In contrast, given thenature of such energizing, a bipolar device with both electrodes on oneshaft makes good electrical contact for the return electrode difficult.

The electrosurgical devices generally include an elongate body having aproximal end, a distal end, and an aspiration lumen extendingtherethrough, an interchangeable tip removably attached to the distalend of the elongate body, and a handle at the proximal end of theelongate body where control mechanisms for cutting and coagulation arelocated. The interchangeable tip typically also has a proximal end, adistal end, and a tip lumen that is fluidly connected to the aspirationlumen of the elongate body. A housing that is secured to the distal endof the interchangeable tip will usually have an aperture and anintegrated blade assembly, e.g., an electrode assembly, that includes anactive electrode. The phrases “blade assembly” and electrode assembly”are used herein interchangeably. In some variations, the activeelectrode is a wire or loop electrode. The blade assembly or portionthereof may define an aspiration port that communicates with theaperture of the housing.

The devices generally include a connector at the proximal end of theinterchangeable tips for removably attaching them to the elongate body.In some variations, the connector comprises a compressible barrel andone or more tabs that are located circumferentially around theconnector. The compressible barrel may be inserted into the distal endof the elongate body to create a friction fit between the components andto thereby removably attach them to one another. The one or more tabsmay be used to attach an ergonomic finger grip to the connector that maymake insertion and removal of the interchangeable tip easier.

The interchangeable tips may be specifically configured foradenoidectomy or tonsillectomy. For example, when adenoidectomy is to beperformed, the devices may include a blade assembly that optimizestissue removal using a raking motion. Here the blade assembly mayinclude an active electrode that has a cutting edge and a flatcoagulation surface. A plurality of arms extending from the activeelectrode may secure the active electrode to the housing. The arms mayhave an angle that positions the cutting edge against the tissue in amanner that allows it to be easily and precisely scooped or shaved intothe aspiration port. The particular arm angle may also be useful inachieving hemostasis by optimizing the position of the coagulationsurface against the tissue. Alternatively, the electrode is a wireelectrode.

When tonsillectomy is to be performed, the devices may include a bladeassembly having a curved and tapered active electrode. This curvaturemay result in a more precise tonsil resection because the electrodesurface approximately conforms to the contour of tonsil tissue. Thecurved and tapered electrode may also define an aspiration porttherethrough. Here bleeding may be more effectively controlled sincesuction may be applied directly through the aspiration port of theelectrode when the device is in the coagulation mode. This would combinemechanical pressure with plasma coagulation to achieve hemostasis.

The interchangeable tips may also be configured to be malleable so thattheir shape can be tailored to navigate access to the tissues oraccommodate variations in patient anatomy. In some instances theinterchangeable tips may be made for single use. Kits including one ormore interchangeable tips are also contemplated.

Methods for resecting tonsil or adenoid tissue may generally includeapplying a pulsed electrical signal to the active electrode of thedevices described herein to form a plasma on the active electrode, andcutting or coagulating the tissue with the plasma. In some variations,suction is applied simultaneously with proximal movement of theelectrode to suction cut the tissue. In other variations, the tissue iscoagulated while suction is simultaneously applied. In yet furthervariations, the methods will include exchanging one interchangeable tip,e.g., a tonsillectomy tip, with another interchangeable tip, e.g., anadenoidectomy tip.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts a side view of an exemplary electrosurgical device withan adenoidectomy tip.

FIG. 1B depicts an expanded side view of the adenoid tip shown in FIG.1A.

FIG. 1C is an expanded perspective view of the blade assembly shown inFIGS. 1A and 1B.

FIG. 1D shows the components of the housing in FIGS. 1A and 1B and howthey are joined to integrate the blade assembly of FIG. 1C.

FIG. 1E is an expanded side view of the blade assembly shown in FIGS.1A-1D.

FIG. 1F shows an expanded inferior view of an exemplary housing andblade assembly for adenoidectomy.

FIG. 1G depicts a variation of the cutting edge that may be used in theblade assembly for adenoidectomy.

FIG. 2A depicts an exemplary housing and blade assembly fortonsillectomy.

FIG. 2B shows the components of the housing in FIG. 2A and how they arejoined to integrate the blade assembly also shown in FIG. 2A.

FIG. 3 is an inferior view (showing the bottom surface) of an exemplaryadenoid tip including a wire as the active electrode.

FIGS. 4A and 4B depict in various views the two main components of thehousing shown in FIG. 3.

DETAILED DESCRIPTION

Described here are electrosurgical devices that can be customized foreither adenoidectomy or tonsillectomy. Customization may be provided bythe use of interchangeable tips that can be removably attached to theelongate body of the device. Specifically, the design of the bladeassemblies and location of the aspiration port from which suction isapplied may be varied to optimize manipulation, cutting, and hemostasisof the tissue being operated on.

The present electrosurgical devices are generally monopolar instead ofbipolar. Both types of devices use high frequency alternating currentand a pair of electrodes, one designated the active electrode and theother the return electrode. However, the difference lies in theplacement of these electrodes. In a monopolar device, current is passedfrom the active electrode through the patient's body to a grounding pad(return electrode) placed on the body, usually the thigh or shoulder. Amonopolar device may be particularly useful in tonsil and adenoidsurgery because contact with the body is guaranteed. In a bipolardevice, the active and return electrodes are both placed at the site ofelectrosurgery, for example, on the same shaft of the device, andelectrosurgery occurs only on the tissue on the active electrode(s) ifthere is a conductive path back to the return electrode.

The devices will generally include an elongate body having a proximalend, a distal end, and an aspiration lumen extending therethrough.Depending on the materials used, all or a portion of the elongate bodymay be formed to be stiff, flexible, or malleable. Exemplary materialsfor making the elongate body include, without limitation,fluoropolymers; thermoplastics such as polyetheretherketone,polyethylene, polyethylene terephthalate, polyurethane, nylon, and thelike; and silicone. Another material is fluoroelastomer.

The elongate body may be between about 5.0 cm to about 20 cm in length.For example, the elongate body may be between about 5.0 cm to about 15cm, between about 5.0 cm to about 10 cm, or between about 5.0 cm toabout 8.0 cm in length. In some instances, the elongate body may beabout 8.0 cm in length. In other instances the devices lack an elongatebody, and the interchangeable tip is directly connected to the handle.

In some variations, the elongate body is coated with a lubriciouspolymer to reduce friction between the mucosa and device during theprocedure. Lubricious polymers are well known in the art, and aretypically hydrophilic. Exemplary hydrophilic polymers that may be usedas lubricious coatings include, without limitation, polyvinyl alcohol,polyethylene glycol, polyvinyl pyrrolidone, cellulosic polymers andpolyethylene oxide.

A handle is usually coupled to the proximal end of the elongate bodythat allows the surgeon to hold the device. The handle may include ahand grip on the bottom and a pad with at least two control buttons onthe top. The control buttons may be depressed to activate electricswitches for turning on the cutting or coagulation regimes. The buttonpad and hand grip are incorporated into the handle using spring clips orother well-know attachments and conventional techniques such asovermolding. A standard electrical connector and cable may be used withthe handle to connect electrical leads to a generator. The handle may bebetween about 5.0 cm to about 30 cm, about 5.0 cm to about 25 cm, about5.0 to about 20 cm, or about 5.0 cm to about 15 cm in length. In onevariation, the handle is about 20 cm in length.

The aspiration lumen of the elongate body continues through the handleto a suction connector, which in turn connects tubing to a collectioncanister. The dimensions of the handle may be varied such that it iscomfortably held in a hand, yet able to be manipulated duringtonsillectomy and adenoidectomy. In some variations, the handle may bemade for single use. As used herein, the term “suction handle” shallrefer to the handle when coupled to the elongate body.

An interchangeable tip, as further described below, may be removablyattached to the distal end of the elongate body. The interchangeable tipwill typically have a proximal end, a distal end, and a tip lumen thatis fluidly connected to the aspiration lumen to allow continuous flow offluids, tissue, smoke, etc. away from the surgical field. The length ofthe interchangeable tip varies, but may be from about 1.0 cm to about 15cm. For example, the adenoidectomy tip may be between about 5.0 cm toabout 10 cm, and the tonsillectomy tip may be from about 1.5 cm to about5.0 cm. In one variation, the adenoidectomy tip is about 9.0 cm. Inanother variation, the tonsillectomy tip is about 2.5 cm. The materialsused to make the elongate body may also be employed in forming theinterchangeable tip.

In one variation, the interchangeable tip is malleable. Malleability maybe provided by wires running through the wall of the elongate body thatare capable of being shaped by bending the elongate body. For example,the wires may be made from stainless steel or alloys thereof,nickel-titanium alloy, etc. Malleability may also be provided by formingthe elongate body or portions thereof with metals or polymers that canbe shaped. In some variations, joints or hinges are included. By havingthe ability to manipulate the shape of the interchangeable tip, it maybe easier and quicker to access the tonsils and adenoids with thedevices and easier to accommodate anatomical variations in that area.The interchangeable tips may be bent directly, e.g., by fingermanipulation, or remotely through cables or wires using mechanismscommonly employed with steerable catheters. The interchangeable tips maybe designed for single use.

The devices generally include a connector at the proximal end of theinterchangeable tips for removably attaching them to the elongate body.An ergonomic finger grip may be used on the connector that may easeinsertion and removal of the interchangeable tip. In some variations,the interchangeable tip may be configured to rotate about the connector.The connectors may be configured to removably attach to the elongatebody by friction fit mechanisms. For example, they may include acompressible component that has a larger diameter when not connected tothe elongate body. Compression of the component typically allows it tobe slidingly engaged with the elongate body at which point the componentis capable of expanding to its uncompressed diameter against theinternal wall of the elongate body. In one variation, the connectorcomprises a compressible barrel and one or more tabs that are locatedcircumferentially around the connector. The compressible barrel may beinserted into the distal end of the elongate body to create a frictionfit between the components and to thereby removably attach them to oneanother. The one or more tabs may be used to attach an ergonomic fingergrip to the connector that may make insertion and removal of theinterchangeable tip easier.

Connection between the elongate body and interchangeable tip may also besupplied by locking-unlocking mechanisms. For example, theinterchangeable tip may include a groove or channel, e.g., a L-shapedchannel, in its wall configured so that upon receipt of a pin or otherprotrusion on the elongate body, the interchangeable tip may be rotatedto be locked in placed. Other tongue-and-groove type locks andmechanisms including depressible pins or tabs are also contemplated.

The electrosurgical devices described here also generally include ahousing at the distal end of the interchangeable tip for holding andsecuring the blade assembly thereto. The housing may be a single unitcomponent or be made from multiple components. For example, the housingmay be made by pressing together two components, an upper portion andlower portion. In some variations, the housing is configured with ablunt nose. In other variations, the housing is designed with a taper.

The housing may include an aperture through which suction can be appliedto the tissues. The aperture may be of any shape and size so long as itprovides an opening for aspiration of smoke, tissue, fluids, etc. Forexample, the aperture may be spherical, elliptical, egg-shaped,rectangular, triangular, diamond-shaped, or heart-shaped. These shapesare not meant to be limiting. When tissue is to be aspirated, theaperture may be larger than conventional suction openings. For example,the aperture may have a diameter from about 0.1 cm to about 1.0 cm. Insome variations, the aperture diameter is larger than about 0.4 cm orabout 0.5 cm.

In addition, the housing may be made from transparent materials orinclude a marker to aid visualization or provide an electrode locator inthe surgical field. Materials with suitable transparency are typicallypolymers such as acrylic copolymers, acrylonitrile butadiene styrene(ABS), polycarbonate, polystyrene, polyvinyl chloride (PVC),polyethylene terephthalate glycol (PETG), and styrene acrylonitrile(SAN). Acrylic copolymers that may be particular useful include, but arenot limited to, polymethyl methacrylate (PMMA) copolymer and styrenemethyl methacrylate (SMMA) copolymer (e.g., Zylar 631® acryliccopolymer).

A blade assembly may be integrated within the housing, and generallyincludes the active electrode. The active electrode typically defines acutting edge. The edge, however, is not like that of an ordinary knifewhich does the cutting solely via mechanical application to the tissuebeing cut. Instead here the edge of the electrode focuses the electricfield induced by the applied electrical signal. This field that isconcentrated at the edge generates a local plasma discharge. In someinstances, the edge is formed by the onlay of metal foil. The tissuecutting may be assisted by mechanical force supplied by the edge of theelectrode, as in conventional cutting, or by application of suction.

The active electrode may be made from any material having suitableelectrical properties. For example, the active electrode may includewithout limitation, metals such as molybdenum, nickel, platinum,stainless steel, tantalum, titanium, tungsten, and alloys thereof.Thickness of the active electrode may be from about 0.1 mm to about 1.0mm thick with an edge of about 10 μm to about 70 μm in thickness. In onevariation, the active electrode thickness is about 0.25 mm (0.01 inch).In another variation, the thickness is about 0.025 mm (0.001 inch). Theactive electrodes may be etched or stamped or machined out of a largesheet of metal, which has been annealed for hardness. The electrodes maybe made from layers, or multiple metals, alloys, or in part fromnon-conductive materials.

An electric insulating layer may be overlaid upon the active electrodeto mostly cover it but leaving an exposed edge or surface that would beused for cutting or coagulation. The insulation is typically a coatingof glass or ceramic approximately 0.005 mm to 0.5 mm thick, or in someinstances approximately 0.01 mm to 0.2 mm thick. When glass insulationis used, it may be applied by a conventional process of dipping eachrelevant component prior to assembly in liquid (molten) glass and thenannealing the glass. The glass insulation may also be applied byspraying.

The configuration of the blade assembly may vary depending on theintended use of the electrode. For example, technical features thatenhance removal of adenoid tissue may differ from other features ofinterest in tonsillectomy. These design features are further elucidatedbelow.

Adenoidectomy Tip

Adenoid tissue, which lies at the back of the nose/throat, may beremoved through the mouth or nose, but typically through the mouth undergeneral anesthesia. Thus, not only are the adenoids difficult to get to,but the presence of an endotracheal tube further cramps an alreadylimited surgical field. The adenoid tips described here areinterchangeable tips specifically configured to address many of thesedifficulties with adenoidectomy.

In one variation, as illustrated in FIG. 1A, electrosurgical device 100includes an elongate body 102 having a proximal end 104 and a distal end106. Proximal end 104 is coupled to a handle 108 where a finger grip 110and pair of control buttons 112 are located. Adenoid tip 114 also has aproximal end 116 and a distal end 118, and is removably attached to theelongate body distal end 106 by a connector 120 positioned at theelongate body distal end 106. Here connector 120 includes a compressiblebasket 121 that can be depressed and slid into the distal end of theelongate body where it will then decompress to expand and create afriction fit against the internal wall of the elongate body (FIG. 1B).The elongate body 102 may be permanently or removably attached to thehandle 108, but will typically be permanently attached. Adenoid tip 114is malleable and can be bent, as shown in FIG. 1A. Here the adenoid tube122 comprises a flexible material such as polyurethane, and includes twolumens (not shown) within its wall where bendable wires (not shown) runlongitudinally between the adenoid tip distal end 118 and proximal end116. Additional lumens and wires may be employed as desired.

Although shown as bent upwards, the adenoid tip may be bent in otherdirections, so long as the device materials or functionality is notcompromised. For example, the adenoid tip may be bent to form an anglewith the elongate body of up to about 45°, up to about 60°, or up toabout 90° or more with respect to the horizontal axis of the elongatebody. Adenoid tip 114 may also be rotated to any angle about the axis ofthe connector 120. As previously mentioned, the bendable nature of theadenoid tip allows easier access to the adenoids. It also provides moreprecise positioning of the active electrode.

The adenoid distal tip also includes a housing for holding the bladeassembly. As shown in FIGS. 1B and 1D, housing 124 is comprised of anupper portion 126 and a lower portion 128 that integrate a bladeassembly 130 when both portions are joined together. Upper 126 and lower128 portions may be joined by snap fitting, adhesives, welding, etc. Thelower portion 128 may have an aperture 132 that defines an aspirationport 152 when the blade assembly 130 is integrated into the housing 124.In some variations, the housing may be formed using a single componentinstead of a plurality of components.

As shown in the enlarged housing-blade assembly of FIG. 1F, the housing124 and integrated blade assembly 130 may define an aspiration port 152,as explained above, through which suction is applied to aspirate fluidsand smoke. However, the aspiration port 152 will generally also bedimensioned so that the device is capable of aspirating tissue throughthe port. In such instances, the port in cross-section may be spherical,ellipsoid, egg-shaped, rectangular, triangular, diamond-shaped, orheart-shaped, and thus wider than conventional suction openings. Herethe aspiration port is about 0.1 cm to about 1.5 cm along its major axisand about 0.1 cm to about 1.0 cm along its minor axis. It is understoodthat these dimensions are exemplary and not limiting.

Bringing the upper and lower housing portions together with the bladeassembly therebetween integrates the blade assembly into the housing.Here the housing is made from a transparent polymer such as Zylar 631®acrylic copolymer (SMMA copolymer) so as not to block visualization atthe adenoid tip distal end 118. Although not shown here, a marker canalso be included on the surface of upper housing portion 126 to indicatethe blade location underneath.

Turning to FIG. 1C, blade assembly 130 includes an active electrode 136having a cutting edge 138 and a coagulation surface 140. A plurality ofarms 142 having a first portion 144 and a second portion 146 secure theactive electrode 134 to the housing 124. The arms may be secured to thehousing with medical grade adhesives such as cyanoacrylate or epoxyadhesives, and other adhesives, which are well known. Referring to FIG.1E, first 144 and second 146 arm portions form an angle 148 of about110° to about 140°. In one variation, a 120° angle is defined betweenthe first 144 and second 146 portions. This angle may optimizeopposition of the coagulation surface 140 onto tissue to effectivelyachieve hemostasis. Further, the angle 148 may optimize the point ofcontact of plasma to the tissue from the cutting edge 138 to effect amore precise cut as well as resection of tissue while minimizingclogging of the aspiration port.

In another variation, as shown in FIG. 1G, the cutting edge 138 may beshaped to include a leading edge 154. The leading edge may aidinitiation of plasma cutting and more effectively remove adenoid tissue.In some variations, the leading edge may extend about 0.2 mm to about2.0 mm from the cutting edge.

After the blade assembly is integrated into the housing, cutting edge138 defines an aspiration port 152 with the aperture 132. With thisadenoid tip configuration, cut adenoid tissue is directly andimmediately suctioned into the aspiration port. Thus, proximal movement(movement toward the operator) of the adenoid tip while simultaneouslymaintaining suction may result in shaving strips of tissue.

Some variations of the adenoid tip include a wire as the activeelectrode. Compared to the other electrode configurations describedherein, use of a wire electrode may particularly improve the cuttingperformance of the adenoid tip. This is because the decreased surfacearea of the wire generally produces less eschar build up, and thus, lesssticking of tissue to the electrode. Furthermore, given that cutting isquicker with a wire electrode, contact of the wire electrode withadenoid tissue is less, resulting in decreased thermal injury to theadenoid tissue in comparison to the electrode configuration depicted inFIGS. 1A-1G (see Example 2). Another advantage of the wire design, e.g.,instead of using the active electrode shown in FIGS. 1A-1G, is that itallows greater freedom of movement during the adenoidectomy procedure.For example, with the active electrode depicted in FIGS. 1A-1G, adenoidtissue would have to be approached at a specific angle because cuttingof the tissue can only be made effectively when made perpendicular tothe adenoids. Given the limited operative field, exposure of theadenoids is already difficult. Limiting the angle of approach would thusfurther frustrate the procedure. When a wire electrode is employed inthe electrode assembly, cutting is not orientation specific. Anotherbenefit is that a wire electrode is generally easier to manufacture thanthe active electrode of FIGS. 1A-1G.

The wire may be completely embedded within the material of the housingexcept for the portion that extends across the housing aperture at thedistal end of the adenoid tip. The wire may be embedded by overmoldingthe wire into a slot provided in the housing. Seating the wire in theslot may also recess the wire a certain distance from the distal end ofthe adenoid tip. For example, the wire may be recessed from the distalend of the adenoid tip a distance ranging from about 0.0005 inch (0.013mm) to about 0.20 inch (5.1 mm). The wire may be of any suitablegeometry, but will typically be round or circular in cross-section, andhave a diameter ranging from about 0.008 inch (0.20 mm) to about 0.010inch (0.25 mm). In another variation, the diameter ranges from about0.005 inch (0.0125 mm) to about 0.020 inch (0.5 mm). In one variation,the wire has a diameter of about 0.008 inch (0.20 mm).

As previously stated, the housing may be of any suitable dimension andgeometry. However, when a wire electrode is used, the housingconfiguration shown in FIGS. 3 and 4A-4B may be particularly suitable.Referring to FIG. 3, adenoid tip 300 includes a housing 302 having atriangular shaped aperture 304. A wire electrode 306 extends across theaperture 304 at the distal end 308 of the adenoid tip 300. The wireelectrode 306 is fully encapsulated, i.e., there is no exposed metal,within the material of the housing except for the portion that extendsacross the aperture 304. Wire electrode 306 is seated in a slot 310 sothat the exposed portion of the wire electrode 306 is recessed from thedistal end 308 of the adenoid tip 300.

Housing 302 is comprised of an upper portion and lower portion, asbetter shown in respectively FIGS. 4A and 4B. In FIG. 4A, upper portion312 (shown in perspective in the upper left part of the figure) has alength of about 0.440 inch (11.18 mm) and is configured to be taperedtoward its distal end 308. The taper (shown in the side view, upperright of the figure) extends over a distance of about 0.315 inch (8.0mm). As shown in the cross-section (lower right in the figure) takenalong line A-A, the width of an opening at the distal end 308 is about0.200 inch (5.1 mm). FIG. 4B shows the lower portion 316 of housing 302(in an x-ray view, left part of the figure). Here the wire 306 isembedded within the material of the housing lower portion 316 except forthe part that extends across triangular shaped aperture 304. The wire306 is also shown recessed a small distance from the distal end 308. Thelength of housing lower portion 316 may be about 0.315 inch (8.0 mm).The aperture 304 may be about 0.144 inch (3.7 mm) in length and about0.170 inch (4.3 mm) in width (at its widest part) (shown in side view,upper right of the figure). The wire 306 will usually extend across theaperture 304 at or near its widest part. Accordingly, in FIG. 4B, theexposed portion of the wire is about 0.170 inch (4.3 mm) long. Thehousing 302 will generally be configured with a profile suitable foraccessing and operating on the adenoids. Is some variations, and asshown in the cross-section (lower right of the figure) taken along lineA-A in FIG. 4B, the lower portion of the housing 316 has a smooth,gradually tapering profile.

The upper portion 312 and lower portion 316 are brought together to makethe housing 302. The upper and lower portions may be joined by methodspreviously described. It is understood that features such as tabs, pins,barbs, hooks, etc., and their corresponding grooves, channels,depressions, and the like, may be included to mate the upper and lowerportions. The upper and lower portions may be fixedly or removablesecured together.

Tonsillectomy Tip

The tonsils are located on either side of the throat and removed undergeneral anesthesia. In this procedure, the unattached end of the tonsilis usually grasped with forceps while an incision is made at the otherend to remove it from the throat. Thus, similar to adenoidectomy, accessis also difficult and the surgical field cramped. The tonsillectomy tipsdescribed here are interchangeable tips specifically configured toaddress many of these difficulties with tonsillectomy.

The suction handle (handle with the elongate body attached) andconnector are generally of the same configuration and made from the samematerials as described for the adenoidectomy tips. The tonsillectomytips may also be malleable and provide the same advantages as thosepreviously described. Further, the housing, blade assembly, and activeelectrode are typically made with the same materials. However, theirconfiguration will differ.

In one variation, as depicted in FIG. 2A, the tonsillectomy tip has ahousing 200 that is tapered. Blade assembly 202 is integrated within thehousing 200. An opening in the active electrode 204 defines anaspiration port 206 through which suction may be applied to a tissuesurface, usually the tonsil bed, as explained above. A rim of activeelectrode results that has a rim thickness 205 from about 0.5 mm toabout 3.0 mm. The rim is insulated except for a about a 5 mm to about a20 mm portion running along the outer edge 209. About a 2 mm to about a15 mm exposed (uninsulated) portion may also run along the inner edge207. Upon application of an energizing electrical signal (waveform),pulsed or continuous, plasma may be formed along the inner 207 and/orouter 209 edges of the rim to cut or coagulate tissue. As previouslymentioned, cutting precision is typically not a result of the degree ofsharpness of the electrode edge, and is not the case here. However, insome variations, one or more sides of the active electrode may besharpened to form about a 10° to 40° edge.

Although shown as a triangular shaped opening in FIGS. 2A and 2B, theaspiration port 206 may take various other shapes. The triangularconfiguration of the aspiration port may optimize suction at the tip ofthe device without compromising the preciseness of tissue dissection.

The active electrode may have a length from about 0.1 cm to about 1.5cm. In one variation, the active electrode has a length of about 0.4 cm.At its widest portion, the active electrode has a width from about 0.1cm to about 1.0 cm. In some instances, the active electrode has a widthof 0.4 cm. The active electrode may also be configured with an upwardcurve so that it approximately conforms to the curvature of the tonsil(e.g., the palatine tonsil). This upward angle of the active electrodemay be of any degree. For example, the upward angle may be from about 5°to about 60°. In some variations, the upward angle is about 30°.

The relationship between the housing and blade assembly components ofFIG. 2A is further detailed in FIG. 2B. In FIG. 2B, housing 200 is shownas being formed by an upper portion 208 and a lower portion 210. A pin212 extending inferiorly from the internal surface of the upper portion208 is threaded through a hole 216 of the blade assembly 214 tointegrate the blade assembly 214 within the housing 200. An adhesive mayfurther be used to secure the housing and blade assembly components toone another.

The housing in FIGS. 2A-2B is shown as tapered, but need not be. In thisvariation, upper portion 208 is longer than bottom portion 210. Theupper portion 208 will generally be from about 0.3 cm to about 3.0 inlength. The bottom portion 210 will generally also be from about 0.3 cmto about 3.0 cm in length. The difference in length between the upperand lower portions results in complete coverage of the aspiration port206 on the top of the active electrode 204 but only partial coverage ofthe aspiration port 206 on the bottom of the active electrode 204. Withthis configuration, suction may be provided through the undersurface ofthe active electrode. The aspiration port 206 may be from about 0.03 cmto about 0.5 cm wide, and about 0.03 cm to about 1.0 cm in length. Inone variation, the aspiration port is about 0.17 cm in width and about0.5 cm in length. A connective piece 218 is also shown in FIG. 2B thatallows the integrated housing and blade assembly to be attached to thetip lumen.

The tonsillectomy tips herein described may provide more precise cuttingand coagulation because of the particular suction electrode design. Herenot only does the aspiration port suction smoke and fluids from theoperative field to improve visualization, but suction and coagulation iscapable of being directly and immediately placed on the tonsil bed fromwhich the tonsil tissue has been resected. This is the raw surface wherehemostasis is needed most, not on the tonsil itself, which is removedfrom the body. The active electrode rim also provides a larger surfacethat could be swept across the tissue to more effectively controlbleeding.

Furthermore, use of the tonsil devices described here may result in lessthermal injury. As further detailed below in Example 1, the depth ofthermal injury was found to be less when the instant tonsil devices wereemployed in comparison to Bovie needles (0.26 mm vs. 0.77 mm) on tonsiltissue. Thermal injury was decreased by 66% when cut settings were usedand by 73% when coagulation settings were used.

The electrical signals (radio frequency in this case) for generating theplasma may be provided by generators and electrical circuits of the kindwell known in the art, or by those described in pending co-ownedapplication Ser. Nos. 11/982,734 and 12/126,683, which are incorporatedby reference in their entirety. The electrical signals areconventionally applied to the electrode by a conductor(s) extendingthrough the electrosurgical device and not shown here. As previouslymentioned, the plasma is formed along the edge of the active electrodeby application of the electrical signals to the electrode. To furtherdecrease the heat accumulation and associated collateral tissue damage,low duty cycle waveforms may be used. As well known, duty-cycle refersto the proportion of time that the electrical energy is actually beingapplied. Low duty-cycle here typically refers to duty-cycles of lessthan 10% which may be, for instance, 1% or less, or 0.1% or less. Insome cases the low duty-cycle refers to the pulse voltage regime that isapplied to the active electrode. For instance, a pulsed low duty-cyclesignal may include a plurality of pulse bursts that are separated bymore than one millisecond (e.g., has a frequency of less than 1 KHz)where each burst is shorter than one millisecond. The burst of pulsesmay include pulses that are biphasic (e.g., of alternating polarity) andthe pulses may have different peak voltages. Again, none of this islimiting. The low duty-cycle is intended to minimize the spread ofthermal injury, including tissue charring or burning. However, in someinstances the devices described here may employ continuous waveforms orduty cycles of greater than about 50% or greater than about 75%.

Cutting or coagulation is generally obtained by energizing the activeelectrode with a suitable electrical signal (typically of differentfrequency, duty-cycle, etc.) for each surgical function. For example,when cutting is desired, the applied signal is an RF (radio frequency)signal having a frequency in the range of 100 KHz to 10 MHz. This energymay be applied in the form of bursts of pulses. Each burst willtypically have a duration in the range of 10 microseconds to 1.0millisecond. The individual pulses in each burst typically each have aduration of 0.1 to 10 microseconds with an interval therebetween of 0.1to 10 microseconds. The actual pulses are typically square waves andbi-phasic, that is alternating positive and negative amplitudes.Generally the interval between pulses must be shorter than a lifetime ofthe plasma vapor cavity in order to maintain the cavity and the plasmaregime during each pulse burst. In one variation the bursts each areseparated by a duration of at least one millisecond. Typically the timebetween the pulse bursts is sufficient so that the duty-cycle isrelatively low as explained above. This minimizes the undesirableheating effects. Coagulation may be achieved in the same manner, but byincreasing output power of the device.

The generator associated with the electrosurgical devices may also allowvarying degrees of cutting and coagulation. For example, in addition toa default power setting when the device is turned on, other settings towhich the device could be adjusted are provided. This would provide insome instances higher hemostasis when cutting.

The electrosurgical devices described here are intended for single use,and can be employed with tonsillectomy, adenoidectomy, or combinedprocedures. In use, the tonsils and/or adenoids are accessed and apulsed electrical signal applied to the active electrode of theinterchangeable tip to form a plasma. In some variations, the activeelectrode is a wire electrode. The tissue is then cut or coagulated withthe plasma. Suction may or may not be used when cutting or coagulating.In some instances, suction is applied simultaneously with proximalmovement (pulling) of the device to suction cut the tissue. In otherinstances, suction is applied through the active electrode, as describedabove.

The electrosurgical devices described here may also be useful in “dryfield” surgical procedures where there is no electrically conductivefluid added to the surgical field to, for example, aid conduction ofenergy between the active and return electrodes and/or to provide acooling effect to the electrodes. When a dry field approach is employed,energy is typically transmitted only by the portion(s) of the activeelectrode that contacts tissue. In this instance the energy can beselectively provided to the areas in which it is desired. Theapplication of suction to the tissue may further remove body fluids thatwould be naturally present in the field to further facilitate tissuecontact.

Contrastingly, in a wet field (e.g., when the active and/or returnelectrodes are immersed or submerged in an electrically conductive fluidprovided from outside the body), all parts of the active electrode thatare in contact with the electrically conductive fluid provide energy. Asa result, more energy than required is generally transmitted to thetissue, and less precisely.

Moreover it has been found that a concave blade does not operate well ina wet field (conductive medium) because components of the blade'selectric field directed in opposite directions cancel each other. Thisdoes not occur in a dry field since current (energy) only flows to thetissue from that part of the blade in direct contact with the tissue.Hence a dry field approach is advantageous here, so the use ofaspiration as described here is beneficial to create the dry field.Further, the suction (aspiration) here directed from the center of theblade pulls the tissue into the aspiration port thereby furtherdecreasing the width of the tissue touching the blade and rendering thefield even drier, thereby further improving the accuracy of current flowand the electric field effects described above.

The interchangeable tip may be exchanged for another at any time duringthe procedure. Thus, it may be useful to provide the suction handle andinterchangeable tips with blade assemblies in a kit. Given that thedevice is intended for single use, one or more suction handles could bepackaged with one or more interchangeable tips with blade assemblies.The interchangeable tips could be of the same type, e.g., alladenoidectomy tips or all tonsillectomy tips, or a mixture of the twotypes. In other instances, the kits may include a plurality ofinterchangeable tips without the suction handle. The interchangeabletips and suction handles may also be individually packaged.

The kits will also generally contain instructions for use. Theinstructions may include directions on how to start, operate, and shutdown the device, as well as directions on how to adjust power levelsettings. Steps for changing one interchangeable tip to another, e.g.,an adenoidectomy tip for a tonsillectomy tip, may also be provided.

The invention described herein will be further understood by thefollowing non-limiting example.

Example 1 Comparative Data on Thermal Injury to Tonsil Tissue

Excised human palatine tonsils were subjected to a series of surgicalincisions using conventional “Bovie” needle tips at settings of 30 W Cutand 30 W Coag. Additional incisions were made using the electrosurgicaltonsillectomy devices described here (“Tonsil Blade”) on settings of Cut5 (20 W power output) for cutting and Coag 6 (30 W power output) forcoagulation. Histology samples were harvested immediately after incisionand evaluated for residual thermal injury using microscopy. A comparisonof the depth of thermal injury (mm) and percent reduction in thermalinjury is provided in Table 1.

TABLE 1 Comparison of Thermal Injury Depth in Tonsil Tissue ThermalInjury Depth (mm) Cut Coag Tonsil Blade 0.26 0.26 (20 W Cut) (30 W Coag)Bovie 0.77 0.96 (30 W Cut) (30 W Coag) Percent Reduction 66% 73% p valuep < 0.05 p < 0.005

Example 2 Comparative Data on Thermal Injury to Adenoid Tissue

Excised porcine adenoid tissue was subjected to a series of incisionsusing an electrosurgical device comprising the active electrodeconfiguration shown in FIGS. 1A-1G at settings of Cut 9 (power output 40W at 600 Ohms with 1930 Volts peak to peak maximum) for cutting and Coag7 (power output 30 W at 1000 Ohms with 3960 Volts peak to peak maximum)for coagulation and Cut 10 (power output 50 W at 600 Ohms with 2110Volts peak to peak maximum) for cutting and Coag 10 (power output 50 Wat 1000 Ohms with 5000 Volts peak to peak maximum) for coagulation.Thermal injury from these incisions was compared to thermal injuryresulting from an electrosurgical device using the wire electrode andhousing design of FIGS. 3 and 4A-4B at the same settings. Histologysamples were harvested immediately after incision and evaluated forresidual thermal injury using microscopy. A comparison of the depth ofthermal injury (mm) is shown in Table 2.

TABLE 2 Comparison of Thermal Injury Depth in Adenoid Tissue Electrodeof FIGS. Settings 1A-1G Wire Electrode Cut 9 0.45 0.32 Coag 7 0.48 0.31Cut 10 0.72 0.26 Coag 10 0.52 0.32

1. An electrosurgical device comprising: a) an elongate body having aproximal end, a distal end, and defining a lumen for applying aspirationextending therethrough; b) a tip having a proximal end, a distal end,and defining a tip lumen fluidly connected to the aspiration lumen atthe distal end of the elongate body; c) a housing secured to the distalend of the tip and defining an aperture fluidly connected to the tiplumen; and d) an electrode assembly in the housing and comprising anactive electrode, wherein the electrode assembly or a portion thereofdefines an aspiration port communicating with the aperture in thehousing.
 2. The electro surgical device of claim 1, wherein the activeelectrode is a wire.
 3. The electro surgical device of claim 2, whereinthe wire has a diameter in the range of about 0.0125 mm to about 0.5 mm.4. The electrosurgical device of claim 3, wherein the wire has adiameter of about 0.2 mm.
 5. A method for resecting tissue using thedevice of claim 1, the method comprising the acts of: a) applying apulsed electrical signal to the electrode to form a plasma thereon; andb) cutting or coagulating the tissue with the plasma.
 6. The method ofclaim 5, further comprising the act of applying suction to the tissuethrough the aspiration port.
 7. The method of claim 6, wherein thesuction is applied during proximal movement of the electrode to suctioncut the tissue.
 8. The device of claim 1, wherein a return electrodeassociated with the active electrode is located remote from the activeelectrode.
 9. The device of claim 1, wherein the tip is malleable. 10.The device of claim 9, wherein the tip includes a plurality of bendablewires extending from the proximal end to the distal end of the tip,whereby the tip is malleably bent and rotated around a longitudinal axisof the elongate body.
 11. The device of claim 1, wherein the activeelectrode is partly covered with an electric insulating layer, with anexposed portion.
 12. The device of claim 1, wherein the active electrodehas a cutting edge and an adjacent planar surface adapted to coagulatetissue.
 13. The device of claim 1, further comprising a plurality ofarms securing the active electrode to the housing, each arm defining abend having an angle in the range of 110° to 140°.
 14. The device ofclaim 12, wherein the active electrode cutting edge includes a leadingedge portion extending from a remainder of the cutting edge by adistance in the range of 0.2 mm to 2.0 mm.
 15. The device of claim 12,wherein the cutting edge and aperture together define the aspirationport.
 16. The device of claim 1, wherein the active electrode defines atriangular central opening that is the aspiration port.
 17. The deviceof claim 16, wherein a rim of the active electrode surrounding thecentral opening has a thickness in the range of 0.5 mm to 3.0 mm and ispartially covered with an electric insulating layer, with a part of anouter edge and an inner edge of the rim being exposed.
 18. The device ofclaim 16, wherein the active electrode has a length and width of about 4mm.
 19. The device of claim 16, wherein the active electrode curves atan angle of about 30°, thereby to conform to curvature of a humantonsil.
 20. The device of claim 16, wherein the housing tapers towardsits distal end at the electrode assembly, wherein the housing covers theaspiration port on one side of the active electrode and only partlycovers the aspiration port on an opposing side of the active electrode.21. The device of claim 16, wherein the aspiration port is about 1.7 mmwide and about 5 mm long.
 22. A method for resecting tissue, comprisingthe acts of: moving an electrode relative to the tissue; applying apulsed electrical signal to the electrode to form a plasma thereon;cutting or coagulating the tissue with the plasma; wherein the electrodeis mounted to a housing defining an aperture which communicates with anaspiration port at the electrode; and applying suction to the aspirationport via the aperture, thereby to suction the cut or coagulated tissue,while moving the electrode relative to the tissue.